Reconstitution of HIV-specific Immunity Against HIV

June 5, 2019 updated by: Linghua LI, Guangzhou 8th People's Hospital
Research Goal: To reconstitute the anti-HIV specific immunity system of the AIDS patients, so the viruses could not massively replicate when HAART was discontinued, then make HIV functional cure possible.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research aims at establishing a new treatment strategies of HIV. It will significantly improve the clinical therapy effects and effectively reduce the morbidity and mortality by reconstituting the immune systems of HIV infected patients and combining multiple therapy strategies. Therefore, the research could develop an cloning amplification system of immunocytes in vitro, and improve the antiviral immune system severely damaged before by transfusing the clone cells modified by specific HIV antigen. So HIV infected patients could discontinue the traditional anti-viral drug, but not develop opportunistic infections,which could obviously increase the life qualities of these patients.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Guangzhou 8th People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. HIV infection confirmed
  2. Receiving HAART more than 6 months
  3. HIV viral-load < 50 copies/ml
  4. Without serious damage of liver and kidney
  5. The subject volunteered to the research and sign the informed consent

Exclusion Criteria:

  1. With serious opportunistic infections
  2. With serious chronic disease such like diabetes, the mental illness,et al
  3. History of suffering from pancreatitis during HAART.
  4. Pregnant and breast-fed.
  5. With poor adherence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIV-specific CD8 cells
Transfusing HIV-specific CD8 cells 50-100mlonce a week for four times.
Biological: HIV-specific CD8 cells
Based on HAART, receive HIV-specific CD8 cells transfuion.
No Intervention: Regualar therapy
Only receiving Highly active anti-retroviral therapy(HAART).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number and function of HIV-specific CD8 cells in patients with HIV
Time Frame: 6 Months
The change of differentiation, proliferation, apoptosis, phenotype, etal.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All adverse events
Time Frame: 6 Months
Chills, Fever, Headache, Nausea, Vomiting, Cough, Skin rashes, Anaphylactic shock, Etal.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou 8th People's Hospital

Collaborators

Sun Yat-sen University

Investigators

  • Principal Investigator: Hui Zhang, doctor, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 13, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013ZX10001004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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